FDA Product Code JAK: System, X-ray, Tomography, Computed
FDA product code JAK covers computed tomography (CT) systems.
These diagnostic imaging systems use rotating X-ray beams and computer processing to generate detailed cross-sectional and three-dimensional images of the body. CT is widely used in emergency medicine, oncology, cardiology, and surgical planning.
JAK devices are Class II medical devices, regulated under 21 CFR 892.1750 and reviewed by the FDA Radiology panel.
Leading manufacturers include Siemens Medical Solutions USA, Inc., Canon Medical Systems Corporation and Shanghai United Imaging Healthcare Co., Ltd..
List of System, X-ray, Tomography, Computed devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, X-ray, Tomography, Computed devices (product code JAK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →